Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h6: part number: 388.720, lot number: t197214, manufacturing site: tuttlingen, release to warehouse date: may 19, 2020, june 5, 2020.A review of the device history records was performed for the finished device lot number and a nonconformance (nc) was started because small pores were visible in the weld seam on a few devices and were reworked.The necessary actions to ensure the final product quality have been taken and documented in the appropriate quality system.The nc have no impact to the complaint condition.The final quality release criteria were met before this batch was released for distribution.The raw material certificate was reviewed and the used material was according to the specification of the device.Visual inspection: the bolt cutter (part# 388.720, lot# t197214) was returned and received at us customer quality (cq).Upon visual inspection, the cutter blade was observed to be broken.No other issues were identified with the returned device.Device failure/defect identified? yes.Dimensional inspection: dimensional inspection of the relevant feature of the received device was not performed at cq due to it being post manufacturing damage.Document/specification review: the following drawing(s) was reviewed: -rod cutter for rods up to 6mm diameter: current and manufactured no design issues or discrepancies were found during this investigation.Complaint confirmed? yes.Conclusion: the complaint condition was confirmed for the bolt cutter (part# 388.720, lot# t197214).No definitive root-cause can be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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